Labelling Specialist - Medical Device Chetan Meditech Pvt Ltd

2.0 - 3.0 years

4 - 6 Lacs

Sanand

Work from Office

Job Title: Labelling Specialist - Medical Devices Location: Sanand, Ahmedabad Department: Quality Assurance Employment Type: Full-Time (On-Site) Reports To: Quality Manager Job Summary: We are seeking a detail-oriented and knowledgeable Labelling Specialist to manage the creation, review, and maintenance of labelling content for our medical devices. The ideal candidate will have a strong understanding of medical device regulations and be well-versed in labelling standards, particularly ISO 15223. This role is critical to ensuring our product labels are compliant, accurate, and aligned with global regulatory requirements. Key Responsibilities: Develop and maintain medical device labels artwork in compliance with applicable regulatory requirements. Ensure labelling content aligns with ISO 15223 (Symbols to be used with medical device labels, labelling and information to be supplied). Collaborate with cross-functional teams including Regulatory Affairs, Quality Assurance, R&D, and Marketing to gather and validate labelling information. Review labelling changes and provide regulatory input during product development and product updates. Ensure labels comply with regional regulations such as MDR (EU), FDA (US), and other relevant markets. Maintain labelling documentation and change control records in accordance with internal procedures. Monitor updates to labelling standards and regulations and assess their impact existing labelling. Qualifications and Requirements: Bachelor's degree in a scientific, engineering, or healthcare-related discipline. Minimum 2 years of experience in a regulated medical device environment, preferably in labelling or regulatory affairs. Strong knowledge of ISO 15223 and other applicable standards (e.g., ISO 20417, IEC 60601, UDI regulations). Familiarity with regulatory requirements for labelling under EU MDR, US FDA, and other global regulations. Experience with labelling software tools (CorelDraw, Adobe Illustrator or similar tools) and document control systems is a plus. Excellent written and verbal communication skills. High attention to detail and ability to work independently and in teams.

Posted 1 month ago

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